Transcatheter valve replacement

ABSTRACT

A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent, a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets, and a deformable frame having a first end and a second end. The frame includes braided wires forming a body having a lumen extending therethrough for receiving the stent and the valve assembly, the body having a plurality of diameters from the first end to the second end.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 13/793,818, filed Mar. 11, 2013.

BACKGROUND OF THE INVENTION

The present disclosure relates to heart valve replacement and, inparticular, to collapsible prosthetic heart valves. More particularly,the present disclosure relates to devices and methods for anchoringcollapsible prosthetic heart valves within the native valve annulus.

Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Thiscollapsibility can avoid the need for a more invasive procedure such asfull open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valvestructure mounted on a stent. There are two types of stents on which thevalve structures are ordinarily mounted: a self-expanding stent and aballoon-expandable stent. To place such valves into a delivery apparatusand ultimately into a patient, the valve must first be collapsed orcrimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant sitein the patient (e.g., at or near the annulus of the patient's heartvalve that is to be replaced by the prosthetic valve), the prostheticvalve can be deployed or released from the delivery apparatus andre-expanded to full operating size. For balloon-expandable valves, thisgenerally involves releasing the entire valve, assuring its properlocation, and then expanding a balloon positioned within the valvestent. For self-expanding valves, on the other hand, the stentautomatically expands as the sheath covering the valve is withdrawn.

SUMMARY OF THE INVENTION

In some embodiments, a prosthetic heart valve having an inflow end andan outflow end may include a collapsible and expandable stent and acollapsible and expandable valve assembly disposed within the stent andhaving a plurality of leaflets. The prosthetic heart valve may furtherinclude a collapsible and expandable frame formed of braided wires, theframe having a body portion and a lumen extending through the bodyportion for receiving the stent and the valve assembly.

In some embodiments, a method of deploying a prosthetic heart valve at atarget site is described. The prosthetic heart valve includes acollapsible and expandable stent, a collapsible and expandable valveassembly disposed within the stent, and a collapsible and expandableframe formed of braided wires, the frame having a body portion and alumen extending through the body portion for receiving the stent and thevalve assembly. The method includes deploying the prosthetic heart valvevia a delivery device at the target site in a collapsed configurationand allowing the prosthetic heart valve to re-expand at the target site,the prosthetic heart valve being coupled to the delivery device,repositioning the prosthetic heart valve at the target site using thedelivery device and decoupling the prosthetic heart valve from thedelivery device after evaluating functionality of the prosthetic heartvalve.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are disclosed herein withreference to the drawings, wherein:

FIG. 1 is a schematic cutaway representation of a human heart showing atransapical delivery approach;

FIG. 2 is a schematic representation of a native mitral valve andassociated cardiac structures;

FIG. 3 is a longitudinal cross-section of one embodiment of a prostheticheart valve having a stent, a valve assembly and a frame;

FIG. 4 is a perspective view of the frame of the prosthetic heart valveof FIG. 3;

FIG. 5A is a perspective view of another embodiment of a frame having apair of flanges;

FIG. 5B is a top view of the frame of FIG. 5A;

FIG. 5C is a perspective view of another embodiment of a frame having apair of flanges and a scalloped lower portion;

FIG. 5D is a perspective view of yet another embodiment of a framehaving a shortened length and a single flange;

FIGS. 6A-I are longitudinal cross-sections of further variations of theframe of a prosthetic heart valve;

FIG. 7A is a longitudinal cross-section of a prosthetic heart valveincluding a frame having a non-circular cross-section;

FIG. 7B is a top view of the prosthetic heart valve of FIG. 7A;

FIG. 7C is a top view of a prosthetic heart valve including a framehaving a triangular transverse cross section;

FIG. 7D is a top view of a prosthetic heart valve including a framehaving a rectangular transverse cross-section;

FIGS. 8A and 8B are top views of prosthetic heart valves having frameswith irregular cross-sections;

FIG. 9 is a longitudinal cross-section of a prosthetic heart valveincluding a frame having an inflow crown;

FIGS. 10A-C are schematic representations showing the staged-deploymentof a prosthetic heart valve; and

FIGS. 11A-C are schematic representations showing repositioning andrecapture of a prosthetic heart valve using a delivery device.

Various embodiments of the present disclosure will now be described withreference to the appended drawings. It is to be appreciated that thesedrawings depict only some embodiments of the disclosure and aretherefore not to be considered limiting of its scope.

DETAILED DESCRIPTION

Despite the various improvements that have been made to collapsibleprosthetic heart valves, conventional devices, systems, and methodssuffer from some shortcomings. In conventional collapsible heart valves,the stent is usually anchored within the native valve annulus via theradial force exerted by the expanding stent against the native valveannulus. If the radial force is too high, damage may occur to hearttissue. If, instead, the radial force is too low, the heart valve maymove from its implanted position, for example, into the left ventricle,requiring emergency surgery to remove the displaced valve. Because thisradial force anchoring partly depends on the presence of calcificationor plaque in the native valve annulus, it may be difficult to properlyanchor the valve in locations where plaque is lacking (e.g., the mitralvalve annulus).

Additionally, in certain situations, as a result of uneven calcificationand irregularities in the native valve annulus, blood may leak aroundthe prosthetic heart valve in a condition known as paravalvular leakage.This leakage enables blood to flow from the left ventricle back into theleft atrium, reducing cardiac efficiency and putting a greater strain onthe heart muscle. Moreover, in certain applications, such as mitralvalve replacement, the heart valve may require a lower profile so as notto interfere with surrounding tissue structures. Such a low profilemakes it difficult for the valve to remain in place.

In view of the foregoing, there is a need for further improvements tothe devices, systems, and methods for prosthetic heart valveimplantation and the anchoring of collapsible prosthetic heart valves,and in particular, self expanding prosthetic heart valves. Among otheradvantages, the present disclosure may address one or more of theseneeds.

Blood flows through the mitral valve from the left atrium to the leftventricle. As used herein, the term “inflow end,” when used inconnection with a prosthetic mitral heart valve, refers to the end ofthe heart valve closest to the left atrium when the heart valve isimplanted in a patient, whereas the term “outflow end,” when used inconnection with a prosthetic heart valve, refers to the end of the heartvalve closest to the left ventricle when the heart valve is implanted ina patient.

FIG. 1 is a schematic cutaway representation of human heart 100. Thehuman heart includes two atria and two ventricles: right atrium 112 andleft atrium 122, and right ventricle 114 and left ventricle 124. Asillustrated in FIG. 1, heart 100 further includes aorta 110, and aorticarch 120. Disposed between the left atrium and the left ventricle ismitral valve 130. Mitral valve 130, also known as the bicuspid valve orleft atrioventricular valve, is a dual-flap that opens as a result ofincreased pressure in left atrium 122 as it fills with blood. As atrialpressure increases above that of left ventricle 124, mitral valve 130opens and blood passes into left ventricle 124. Blood flows throughheart 100 in the direction shown by arrows “B”.

A dashed arrow, labeled as “TA”, indicates a transapical approach ofimplanting a prosthetic heart valve, in this case to replace the mitralvalve. In transapical delivery, a small incision is made between theribs and into the apex of left ventricle 124 to deliver the prostheticheart valve to the target site.

FIG. 2 is a more detailed schematic representation of native mitralvalve 130 and its associated structures. As previously noted, mitralvalve 130 includes two flaps or leaflets, posterior leaflet 136 andanterior leaflet 138, disposed between left atrium 122 and leftventricle 124. Cord-like tendons, known as chordae tendineae 134,connect the two leaflets 136, 138 to the medial and lateral papillarymuscles 132. During atrial systole, blood flows from higher pressure inleft atrium 122 to lower pressure in left ventricle 124. When leftventricle 124 contracts in ventricular systole, the increased bloodpressure in the chamber pushes leaflets 136, 138 to close, preventingthe backflow of blood into left atrium 122. Since the blood pressure inleft atrium 122 is much lower than that in left ventricle 124, leaflets136, 138 attempt to evert to the low pressure regions. Chordae tendineae134 prevent the eversion by becoming tense, thus pulling on leaflets136, 138 and holding them in the closed position.

FIG. 3 is a longitudinal cross-section of prosthetic heart valve 200 inaccordance with one embodiment of the present disclosure. Prostheticheart valve 200 is a collapsible prosthetic heart valve designed toreplace the function of the native mitral valve of a patient (see nativemitral valve 130 of FIGS. 1-2). Generally, prosthetic valve 200 hasinflow end 210 and outflow end 212. Prosthetic valve 200 may besubstantially cylindrically shaped and may include features foranchoring, as will be discussed in more detail below. When used toreplace native mitral valve 130 (shown in FIGS. 1-2), prosthetic valve200 may have a low profile so as not to interfere with atrial function.

Prosthetic heart valve 200 may include stent 250, which may be formedfrom biocompatible materials that are capable of self-expansion, suchas, for example, shape memory alloys including nitinol. Stent 250 mayinclude a plurality of struts 252 that form cells 254 connected to oneanother in one or more annular rows around the stent. Cells 254 may allbe of substantially the same size around the perimeter and along thelength of stent 250. Alternatively, cells 254 near inflow end 210 may belarger than the cells near outflow end 212. Stent 250 may be expandableto provide a radial force to assist with positioning and stabilizingprosthetic heart valve 200.

Prosthetic heart valve 200 may also include valve assembly 260 includinga pair of leaflets 262 attached to a cylindrical cuff 264. Leaflets 262replace the function of native mitral valve leaflets 136 and 138described above with reference to FIG. 2. That is, leaflets 262 coaptwith one another to function as a one-way valve. It will be appreciated,however, that prosthetic heart valve 200 may have more than two leafletswhen used to replace a mitral valve or other cardiac valves within apatient. Valve assembly 260 of prosthetic heart valve 200 may besubstantially cylindrical, or may taper outwardly from outflow end 212to inflow end 210. Both cuff 264 and leaflets 262 may be wholly orpartly formed of any suitable biological material, such as bovine orporcine pericardium, or polymers, such as PTFE, urethanes and the like.

When used to replace a native mitral valve, valve assembly 260 may besized in the range of about 20 mm to about mm in diameter. Valveassembly 260 may be secured to stent 250 by suturing to struts 252 or byusing tissue glue, ultrasonic welding or other suitable methods.Alternatively, in embodiments not having a stent, valve assembly 260 maybe directly attached to frame 300 using any of the aforementionedmethods.

Frame 300 of prosthetic heart valve 200 may surround and house valveassembly 260 and stent 250. Frame 300 may be formed of a braidedmaterial, such as nitinol, in various configurations to create varyingshapes and/or geometries to engage tissue and fill the spaces betweenvalve assembly 260 and the native valve annulus. Several of theseconfigurations will be described below with reference to FIGS. 4-9.

As shown in FIG. 4, frame 300 includes a plurality of braided strands orwires 305 arranged in three-dimensional shapes. In one example, wires305 form a braided metal fabric that is both resilient and capable ofheat treatment to substantially set a desired preset shape. One class ofmaterials which meets these qualifications is shape memory alloys. Oneexample of a shape memory alloy is Nitinol. It is also understood wires305 may comprise various materials other than Nitinol that have elasticand/or memory properties, such as spring stainless steel, trade namedalloys such as Elgiloy®, Hastelloy®, CoCrNi alloys (e.g., trade namePhynox), MP35N®, CoCrMo alloys, or a mixture of metal and polymerfibers. Depending on the individual material selected, strand diameter,number of strands, and pitch may be altered to achieve the desiredproperties of frame 300.

In the simplest configuration of frame 300, shown in FIG. 4, frame 300may be formed in a cylindrical or tubular configuration having inlet end310, outlet end 312 and lumen 315 extending between inlet end 310 andoutlet end 312 for housing stent 250 and valve assembly 260. Frame 300may be formed of a shape-memory material capable of being radiallycollapsed from a relaxed or preset configuration to a compressed orreduced configuration for delivery into the patient. Once released afterdelivery, frame 300 may re-expand to its relaxed or presetconfiguration. Frame 300 may also be locally compliant in a radialdirection such that a force exerted in the direction of arrow F deformsa portion of the frame, as shown by the indented region C. In thismanner, irregularities in the native valve annulus may be filled byframe 300, thereby preventing paravalvular leakage. Moreover, portionsof frame 300, such as the flanges described below, may endothelializeand in-grow into the heart wall over time, providing permanent stabilityand a low thrombus surface.

As shown in FIG. 4, frame 300 has been described as having asubstantially cylindrical configuration. When prosthetic heart valve 200utilizes such a frame, radial forces exerted by expanding frame 300,stent 250 and/or valve assembly 260 anchor prosthetic heart valve 200within the native annulus. In some examples, valve assembly 260 mayexert a radial force either in conjunction with or independently offrame 300. It may be possible for frame 300 to include additionalfeatures capable of anchoring and sealing a prosthetic heart valvewithin the native valve annulus, which are discussed below withreference to FIGS. 5A-5D.

FIGS. 5A-D illustrate embodiments of frame 300 having anchoringfeatures. Frame 300 may be formed of a braided wires 305 shaped in acylindrical or tubular body 308 having inlet end 310, outlet end 312 andlumen 315 extending between inlet and outlet ends 310, 312 for housingstent 250 and valve assembly 260. Frame 300 may further include an upperflange 320 and a lower flange 322 as will be described in greater detailbelow. As shown throughout FIGS. 5A-5D, free ends of braided wires 305may be held together at inlet end 310 via first clamp or crimp tube 335and at outlet end 312 via second clamp or crimp tube 337. In alternativeembodiments, free ends are located at only one end of frame 300 and/orsecured to prevent unraveling by other means (e.g. solder, braze, weld,or heat set). Crimp tube 337 may be internally or externally threaded ormay include other suitable means as recognized by people skilled in theart for releasable connection to a device for delivery and recapture ofthe prosthetic heart valve. Other means of attachment for frame 300 anda delivery device include press fit, snap fit, compression fit, tethers,hook and clasps or other mechanical mating arrangements. In someexamples, crimp tube 337 may be a section of tubing configured such thatwhen a braid or portion of braid or any portion of a device is insertedin the tube, it may be crimped down on the outside by mechanical meansthereby securing the two together. The other end of the tube may have ameans of attachment such as an internal screw thread to then be able toattach to an externally threaded delivery wire or cable which extendsoutside the body.

As shown in FIG. 5A, frame 300A may be heat set to form upper flange 320near inlet end 310 and lower flange 322 near outlet end 312, with agenerally cylindrical body portion 308 therebetween. Upper flange 320may be configured to engage a portion of the left atrium, while lowerflange 322 may be configured to engage a portion of the left ventricleand/or papillary muscles (see FIGS. 1-2). Collectively, upper flange320, lower flange 322 and body portion 308 may form a frame in a spindleor hourglass shape that straddles the mitral valve position, fittingwithin the native valve annulus to prevent prosthetic heart valve 200from being dislodged from its intended location. FIG. 5B is a top viewof frame 300A from FIG. 5A showing lumen 315 and upper flange 320. Itwill be understood that the radial distance “d₁” by which flanges320,322 extend from body portion 308 may be varied as desired.Additionally, as seen in FIG. 5A, upper flange 320 may taper outwardlyfrom body portion 308 toward inlet end 310 and lower flange 322 maytaper outwardly from body portion 308 to outlet end 312.

FIG. 5C illustrates another embodiment of frame 300B. Frame 300B may beformed of braided wires 305 shaped into body 308 having inlet end 310,outlet end 312 and lumen 315 extending between inlet and outlet ends310, 312. Frame 300B may further include upper flange 320, lower flange322B and first and second crimp tubes 335,337. In this variation, lowerflange 322B includes scalloped portion 340 in which a portion of braidedwires 305 is removed so as to improve the blood flow through outflow end312 and prevent interference with the left ventricular outflow tract.Scalloped portion 340 may form an inwardly bent outline such that outletend 312 forms a concave curve as shown in FIG. 5C. Instead of removingmaterial from lower flange 322B to form scalloped portion 340, portionsof lower flange 322B may be heat set or otherwise shaped via a mold orother suitable means to form scalloped portion 340 in the configurationshown.

FIG. 5D illustrates frame 300C formed of braided wires 305 shaped intobody 308C having inlet end 310, outlet end 312 and lumen 315 extendingbetween inlet and outlet ends 310, 312. Frame 300C may further includeupper flange 320 and first and second crimp tubes 335,337. Rather thanforming a scalloped portion 340 in flange 322, it will be understoodthat frame 300C may instead have only an upper flange 320, as shown inFIG. 5D, and a shortened overall length of body 308C to preventinterference with the left ventricular outflow tract.

FIGS. 6A-G illustrate several additional variants of frame 300. In afirst variant, shown in FIG. 6A, frame 300D includes upper flange 320Dnear inlet end 310 and lower flange 322D near outlet end 312, with bodyportion 308 therebetween. Upper flange 320D and lower flange 322D areboth substantially perpendicular to the longitudinal axis L1 of frame300D, resulting in a spindle-shaped frame. In another variant, shown inFIG. 6B, upper flange 320E and lower flange 322E of frame 300E formabout a 45 degree angle with longitudinal axis L1 of frame 300E asindicated by angle r. It will be understood that the angle which upperflange 320 and lower flange 322 form with the axial length of frame 300may be from greater than 0 degrees to less than 180 degrees.Additionally, it will be understood that upper flange 320 and lowerflange 322 need not be symmetric. In other words, the angles that thetwo flanges form with respect to the longitudinal axis of frame 300 maybe different from one another.

FIG. 6C illustrates frame 300F including upper flange 320F, lower flange322F and a dilated body portion 308F. Dilated body portion 308F may havea radially expanded shape between upper flange 320F and lower flange322F that is generally in the form of a sphere, with a longitudinalcross-section that is generally circular. However, it will be understoodthat other shapes are possible, including those that have longitudinalcross-sections that are triangular, square, rectangular or ovular.Dilated body portion 308F may aid in sealing the prosthetic valve withinthe native valve annulus and reduce the risk of paravalvular leakage byfilling any gaps between the prosthetic valve and the native valveannulus walls with conformable wires 305. In one variation of thisconstruction shown in FIG. 6D, instead of the one-piece frame shown inFIG. 6C, frame 300G may include a first braided portion 342 includingupper flange 320G, lower flange 322G and a substantially cylindricalbody portion 308G, and a second braided portion 344 disposed about bodyportion 308G and forming dilated body portion 346.

As seen in FIG. 6E-6G, additional features may be added to upper flange320 and lower flange 322 to improve anchoring. For example, theconfigurations of upper flange 320 and lower flange 322 may be modifiedfor improved engagement with the native valve annulus. Referring toframe 300H in FIG. 6E, upper flange 320H and lower flange 322H mayinclude secondary bends 350, 352, respectively, for engaging hearttissue. Atrial secondary bend 350 may extend back toward body portion308 of frame 300H and may be configured to contact a portion of theatrium, while ventricular secondary bend 352 may extend back toward bodyportion 308 of frame 300H and may be configured to contact a portion ofthe ventricle. It will be understood that the length and angle ofsecondary bends 350, 352 may be varied as needed.

Likewise, in order to better anchor frame 300 within the native valveannulus, stabilizing wires 354 may be coupled to upper flange 320I andlower flange 322I as shown on frame 300I in FIG. 6F. Each stabilizingwire 354 may include a barb or hook 356 at its free end. Hook 356 may bemanipulated by conventional snares to aid in the delivery of frame 300.Additionally, hooks 356 may be manipulated by one or more snares (notshown) to aid in repositioning frame 300I within the native valveannulus. For example, as will be seen in the following examples, frame300I may be radially asymmetric and may need to be rotated with thenative valve annulus to properly seat the valve assembly. In addition,frame 300I may need to be recaptured and removed for several reasonsincluding improper fitment, inadequate sealing and similar sizing andfitment issues. In such cases, a snare may be used to grasp hooks 356and pull frame 300 back into a delivery catheter to remove or redeploythe frame.

Moreover, in addition to secondary bends and stabilizing wires,dumbbell-shaped anchors 360 having flared ends 361 a, 361 b may aid inlocking upper flange 320 and/or lower flange 322 to heart tissue 450, asseen in FIG. 6G with respect to frame 300J. Any number ofdumbbell-shaped anchors 360 may be used to couple each flange 320, 322to heart tissue and may be delivered separately to the site of theprosthetic heart valve. Each dumbbell-shaped anchor 360 may piercethrough tissue near native valve annulus 450 and through upper flange320 or lower flange 322, thereby attaching flange 320, 322 to the nativetissue. In some examples, anchors 360 may be delivered in the samemanner as the heart valve. For example, anchors 360 may be delivered viaa catheter and made to pierce upper or lower flange 320, 322, end 361 aof anchor 360 may secure one end of the anchor to the flange. Second end361 b of anchor 360 may then be deployed on the tissue side, piercingheart tissue 450 and securing the anchor 360 to the tissue.

To prevent paravalvular leakage, various means could be used to sealflanges 320, 322. In one example, frame 300K shown in FIG. 6H includesreinforcement 355 sewn into the upper and lower flanges 320K, 322K.Reinforcement 335 may comprise polyester strands, braided polystrand,patch materials or a fabric, or any acceptable bio-compatible fabric orother material (including but not limited to: polyester,Polytetrafluoroethylene (PTFE), microporous material formed bystretching PTFE, known as ePTFE). Reinforcement 355 may promote tissuegrowth, thereby reducing the amount of paravalvular leakage. In anothervariation, shown as frame 300L in FIG. 6I, reinforcement 355L may bedisposed not only in upper flange 320L and lower flange 322L, but alsothroughout body portion 308L, and may be capable of expanding andcollapsing with frame 300L.

Though the previous examples have described frame 300 as having acircular transverse cross-section as shown in FIG. 5B, it will beunderstood that frame 300 may be modified as desired. For example, FIG.7A is a longitudinal cross-section of a further embodiment of prostheticheart valve 200M and FIG. 7B is the corresponding top view thereof. Asseen in FIG. 7B, prosthetic heart valve 200M includes frame 300M, withvalve assembly 260 having leaflets 262 disposed within frame 300M andsupported by stent 250. Valve assembly 260 has a circular transversecross-section while frame 300M has an oblong transverse cross-section.In many circumstances, the native valve annulus is not circular, butrather is “D-shaped”. Due to the non-circular cross-section of frame300M and the non-circular geometry of the native valve annulus, properplacement of prosthetic heart valve 200M may require a specificorientation. As shown in FIG. 7B, prosthetic heart valve 200M mayinclude one or more markers 410 to aid in such orientation. Markers 410may include radiopaque structures (e.g., platinum dots or stitches) toallow for visualization of frame 300M within the patient during deliveryand/or use. Markers 410 may be disposed on diametrically opposed sidesof frame 300M. However, it will be understood that markers 410 may bedisposed on any portion of frame 300M, stent 250 and/or valve assembly260.

FIGS. 7C and 7D illustrate prosthetic heart valves 200 having some othervariations of frame 300. In FIG. 7C, prosthetic heart valve 200Nincludes frame 300N having a triangular transverse cross-section with acircular stent 250 and valve assembly 260 disposed therein. FIG. 7Dillustrates prosthetic heart valve 200O having frame 300O with arectangular transverse cross-section supporting a circular stent 250 andvalve assembly 260. One or more markers 410 may be used to determine theorientation of the device as described above.

It will be understood that frame 300 need not be limited to basicgeometric shapes. For example, FIGS. 8A and 8B are top views ofprosthetic heart valves 200 having irregular transverse cross-sections.Frame 300P of FIG. 8A has a substantially circular transversecross-section and a pair of enlarged regions 390 each having markers410. Enlarged regions 390 may extend along the length of body 308 andmay be continuous therewith. Enlarged regions 390 may aid in providingstability to the anchoring of prosthetic heart valve 200P or in reducingparavalvular leakage. FIG. 8B illustrates another variation in whichframe 300Q of prosthetic heart valve 200Q has an irregular cross-sectionwith four enlarged regions 390Q at the corners of the frame. Markers 410may be disposed on one or more of enlarged regions 390Q to aid inorienting prosthetic heart valve 200Q. Such irregular shapes of frame390Q may be molded as need and may be useful for preventing paravalvularleakage in an unevenly calcified native valve annulus or in an annulushaving an unresected native leaflet.

FIG. 9 is a longitudinal cross-section of another variation ofprosthetic heart valve 200R. As with the previous embodiments,prosthetic heart valve 200R has an inflow end 210R and an outflow end212, and includes stent 250, valve assembly 260 having leaflets 262, andbraided frame 300R. A portion of frame 300R may be formed into inflowcrown 910 instead of upper flanges (compare upper flange 230 of FIG.5A). Inflow crown 910 may be configured as a generally hemisphericalstructure made of braided wires 305 shaped to fit within the left atriumwhen prosthetic heart valve 200R is used to replace a native mitralvalve. Inflow crown 910 may be sized to fill a portion of, all of, orsubstantially all of the left atrium to aid in anchoring prostheticheart valve 200R within the patient's anatomy. In some variations, thesize of inflow crown 910 may be selected based on an analysis of thepatient's anatomy. Inflow crown 910 includes a plurality of large pores915 sized to allow unimpeded blood flow into the left atrium from thepulmonary veins.

The prosthetic heart valves described above may be used to replace anative heart valve, such as the mitral valve, a surgical heart valve ora heart valve that has undergone a surgical procedure. Prosthetic heartvalve 200 may be delivered to the desired site (e.g., near a nativemitral annulus) using any suitable delivery device. During delivery, theprosthetic heart valve may be disposed inside the delivery device in thecompressed configuration. The delivery device may be introduced into thepatient using a transapical or other percutaneous approach. For example,prosthetic heart valve 200 may be delivered as an assembled, single unitinto the mitral valve annulus to replace the function of a diseased ormalfunctioning native mitral valve or previously implanted prosthesis.Specifically, frame 300, stent 250 and valve assembly 260 may beradially collapsed, introduced to the native valve annulus throughtranscatheter delivery and re-expanded in unison.

Once the delivery device has reached the target site, the user maydeploy prosthetic heart valve 200. Upon deployment, prosthetic heartvalve 200 expands into secure engagement within the native anatomicstructure, such as the mitral valve annulus (shown in FIGS. 1-2), andradial forces keep prosthetic heart valve 200 in place. When prostheticheart valve 200 is properly positioned inside the patient, it works as aone-way valve, allowing blood to flow in one direction (e.g., from theleft atrium to the left ventricle) while preventing blood from flowingin the opposite direction.

Alternatively, prosthetic heart valve 200 may utilize staged-deploymentin which the various elements of heart valve 200 are deployed separatelyand then reassembled within the native valve annulus. Separate deliveryof elements, such as illustrated in FIGS. 10A-C, may allow for a reduceddelivery profile.

FIG. 10A illustrates a first stage in which a first catheter 1000 isintroduced toward the native mitral valve annulus 450. In the depictedembodiment, first catheter 1000 is delivered from the left ventricle inthe direction of arrow D through a transapical approach, although otherpercutaneous approaches are possible. Catheter 1000 houses frame 300,which has been radially collapsed to reduce the delivery profile of thedevice. Once catheter 1000 has been properly positioned within nativevalve annulus 450, frame 300 may be pushed out or otherwise releasedfrom first catheter 1000 using any suitable method and allowed toradially re-expand into its relaxed configuration, filling native valveannulus 450 and forming lumen 315 (FIG. 10B). At this stage, it may benecessary to adjust frame 300 within native valve annulus 450, forexample, to open lumen 315 or to properly orient frame 300 within nativevalve annulus 450.

Once frame 300 has been properly positioned, a second stage may begin byintroducing second catheter 1002 toward native valve annulus 450. Secondcatheter 1002 may be delivered using the same approach as first catheter1000, although it will be understood that the two catheters may utilizedifferent approaches. In the illustrated example, second catheter 1002houses stent 250 and valve assembly 260, both of which have beenradially collapsed. Second catheter 1002 may be introduced in thedirection of arrow D and the stent and valve assembly combinationreleased inside lumen 315 of frame 300. With stent 250 and valveassembly 260 released from second catheter 1002, the two components mayradially self-expand within frame 300, pushing the frame against thewalls of native valve annulus 450 while becoming seated and properlysecured within the frame via radial forces.

FIG. 10C illustrates prosthetic heart valve 200 after being fullyreassembled within native valve annulus 450. When prosthetic heart valve200 is properly positioned inside the patient, it works as a one-wayvalve, allowing blood to flow in one direction (e.g., from the leftatrium to the left ventricle) and preventing blood from flowing in theopposite direction. Over time, tissue will grow on and into frame 300and prosthetic heart valve 200 will experience better sealing andanchoring within the native valve annulus.

FIGS. 11A-C illustrate one method of using a delivery device to properlyposition prosthetic heart valve 200S within native valve annulus 450.Specifically, frame 300S may be configured for partial deployment,resheathing and redeployment from delivery device 1100. Delivery device1100 may be configured to mate with frame 300S to couple prostheticheart valve 200S to the delivery device. Delivery device 1100 can takeany suitable shape, but desirably comprises a hollow catheter 1000S andan elongate flexible shaft 1102 having an externally threaded distal end1104 disposed within catheter 1000S. Frame 300S may further includecrimp tube 337S having inner thread 339, which is configured to matewith threaded distal end 1104 of shaft 1102. Delivery device 1100 may beused to urge prosthetic heart valve 200S through the lumen of catheter1000S for deployment in a patient's body. As seen in FIGS. 11A and 11B,when prosthetic heart valve 200S is deployed out the distal end ofcatheter 1000S, it will still be retained by delivery device 1100through the coupling of inner thread 339 to threaded distal end 1104.Once prosthetic heart valve 200S is properly positioned within thepatient, shaft 1102 can be rotated about its axis to unscrew crimp tube337S of prosthetic heart valve 200S from threaded distal end 1104 ofshaft 1102. Delivery device 1100 including catheter 1000S and shaft 1102may then be withdrawn (FIG. 11C).

By keeping prosthetic heart valve 200S attached to delivery device 1100,the operator can evaluate the function of leaflets 262 to ensureadequate coaptation and opening. The operator may retract prostheticheart valve 200S within catheter 1000S for repositioning, even afterfull deployment from catheter 1000S, if it is determined that prostheticheart valve 200S is not properly positioned. Thus, if fitment orpositioning appears to be incorrect, prosthetic heart valve 200S may berecaptured within catheter 1000S and redeployed, if possible untilproper placement is achieved.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. For example, any combination offlanges, hooks or scalloped portions may be combined in a prostheticheart valve. Additionally, a prosthetic heart valve may include anynumber of markers at any desired location. Additionally, it will beunderstood that while a transapical delivery approach has beendescribed, the present disclosure contemplates the use of transseptaldelivery as well as less conventional approaches, such as direct accessto the left atrium or access into the left atrium via the left arterialappendage or the pulmonary veins. It is also conceivable that the devicemay be delivered by passing through the femoral artery, the aortic valveand the left ventricle. It will be appreciated that any of the featuresdescribed in connection with individual embodiments may be shared withothers of the described embodiments.

For example, the frame may include at least one flange having atransverse cross-section greater than a transverse cross-section of thebody portion for anchoring the frame within a native valve annulus. Theat least one flange may be adjacent the inflow end of the prostheticheart valve. The at least one flange may also be adjacent the outflowend of the prosthetic heart valve. The at least one flange may include asecondary bend extending back toward the body portion of the frame.

A stabilizing wire may be disposed on the at least one flange andconfigured to engage heart tissue. The device may further include adumbbell-shaped anchor for coupling the at least one flange to hearttissue. The frame may include a scalloped portion adjacent the outflowend of the prosthetic heart valve. The frame may extend in alongitudinal direction between the inflow end and the outflow end of theprosthetic heart valve, the body portion of the frame including adilated portion having a longitudinal cross-section that issubstantially circular. The valve may further include reinforcementcoupled to the frame to promote tissue growth. The reinforcement mayinclude polyester strands. The frame may have a non-circular transversecross-section such as an oblong transverse cross-section.

The heart valve may further include at least one radiopaque markerdisposed on at least one of the frame, the stent and the valve assembly.The prosthetic heart valve may be configured to replace a native mitralvalve. The valve assembly may include two leaflets. The frame mayinclude a hemispherical inflow crown configured to fit within the leftatrium of a patient.

When utilizing the methods described above, the frame, the stent and thevalve assembly may be deployed simultaneously. Alternatively, the frame,the stent and the valve assembly may be deployed sequentially. The framemay be deployed using a first catheter and the stent and the valveassembly deployed using a second catheter after the frame is deployed.The target site may be the mitral valve annulus of a patient.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

The invention claimed is:
 1. A prosthetic heart valve having an inflowend and an outflow end, comprising: a collapsible and expandable stenthaving a plurality of struts; a collapsible and expandable valveassembly disposed within the stent and having a plurality of leafletsconfigured to permit a blood flow in a first direction from the inflowend to the outflow end, and to impede the blood flow in a secondopposite direction; and a deformable frame having a first end and asecond end, the frame including a plurality of shape-memory metallicwires that are braided together to form a three-dimensional bodydefining an inner surface in contact with struts of the stent, an outersurface for contacting native tissue, the body having a thicknessbetween the inner surface and the outer surface, the thickness beingvariable from a first distance in an uncompressed state, and a seconddistance when a force is applied to the body, the second distance beingless than the first distance, the body having a lumen extendingtherethrough for receiving the stent and the valve assembly.
 2. Theprosthetic heart valve of claim 1, wherein the frame further comprisesat least one hook configured to engage heart tissue.
 3. The prostheticheart valve of claim 1, wherein the body includes a first diameter andat least one flange having a second diameter that is larger than thefirst diameter for anchoring the body within a native valve annulus. 4.The prosthetic heart valve of claim 3, wherein the at least one flangeis disposed adjacent the outflow end of the prosthetic heart valve. 5.The prosthetic heart valve of claim 3, wherein the at least one flangeincludes a first section that extends away from the body and a secondsection that extends back toward the body.
 6. The prosthetic heart valveof claim 3, further comprising a stabilizing wire disposed on the atleast one flange and configured to engage heart tissue.
 7. Theprosthetic heart valve of claim 3, further comprising a dumbbell-shapedanchor for coupling the at least one flange to heart tissue.
 8. Theprosthetic heart valve of claim 1, wherein the frame includes ascalloped portion adjacent the outflow end of the prosthetic heartvalve.
 9. The prosthetic heart valve of claim 1, wherein the frameextends in a longitudinal direction between the inflow end and theoutflow end of the prosthetic heart valve, the body portion of the frameincluding a dilated portion having a longitudinal cross-section that issubstantially circular.
 10. The prosthetic heart valve of claim 9,wherein the prosthetic heart valve is configured to replace a nativemitral valve.
 11. The prosthetic heart valve of claim 9, wherein thevalve assembly includes two leaflets.
 12. The prosthetic heart valve ofclaim 1, further comprising a reinforcement coupled to the frame topromote tissue growth.
 13. The prosthetic heart valve of claim 12,wherein the reinforcement includes polyester strands.
 14. The prostheticheart valve of claim 12, wherein the frame has a non-circular transversecross-section.
 15. A method of deploying a prosthetic heart valve at atarget site, the prosthetic heart valve including a stent having aplurality of struts, a valve assembly disposed within the stent andconfigured to permit a blood flow in a first direction from the inflowend to the outflow end, and to impede the blood flow in a secondopposite direction, and a deformable frame having a first end and asecond end, the frame including a plurality of shape-memory metallicwires that are braided together to form a three-dimensional bodydefining an inner surface in contact with struts of the stent, an outersurface for contacting native tissue, the body having a thicknessbetween the inner surface and the outer surface, the thickness beingvariable from a first distance in an uncompressed state, and a seconddistance when a force is applied to the body, the second radial distancebeing less than the first radial distance, the body having a lumenextending therethrough for receiving the stent and the valve assembly,the method comprising: deploying the deformable frame at the target siteand allowing the frame to expand to fill irregularities in the nativevalve annulus; and deploying the stent and valve via a delivery devicewithin the expanded frame.
 16. The method of claim 15, wherein thetarget site is the mitral valve annulus of a patient.
 17. The method ofclaim 15, wherein the delivery device comprises a catheter and an innershaft, the inner shaft being configured to mate with the stent.
 18. Themethod of claim 15, further comprising recapturing the stent within thecatheter after expansion at the target site.